US FDA warns 3 baby formula makers to correct manufacturing process controls

Aug 30 (Reuters) – The U.S. Food and Drug Administration on Wednesday issued warnings to three infant formula makers to correct their manufacturing processes to better catch bacterial contamination, but added it does not expect any impact on the supply.

The regulator issued warning letters to ByHeart Inc, Reckitt Benckiser Group’s (RKT.L) Mead Johnson Nutrition and Perrigo’s (PRGO.N) Wisconsin unit.

The FDA pulled up these companies for failing to establish processes to ensure infant formula does not become contaminated during manufacturing.

“We are in the process of carefully reviewing the FDA’s letter and plan to work closely with the agency,” a spokesperson for Perrigo said, adding all their infant formula products that were available to parents and caregivers comply with the FDA’s food safety requirements.

The FDA’s warning letters are not associated with any current recalls, and were related to observations following recalls by the three companies between December and March, the agency said.

The recalls were meant to remove products potentially contaminated with the bacteria cronobacter sakazakii, the FDA added.

“The agency… believes that the recalls were effective in removing the potentially contaminated batches of product from the market,” the FDA said.

Infant formula manufacturing is under greater scrutiny following the shortage of the product last year due to a shutdown of Abbott Laboratories’ (ABT.N) unit in Michigan.

The formulas produced at Abbott’s facility faced complaints of bacterial infections, leading to recalls and the shutdown.

Reckitt and ByHeart did not immediately respond to requests for a comment.

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